Centre proposes doing away with double testing of blood plasma products

Union Health Ministry moves to remove repeated HIV, Hepatitis tests on pooled plasma to align with global norms and ease compliance while maintaining patient safety

To ensure regulatory harmonisation in testing blood products with global norms, the Centre has proposed doing away with testing of pooled blood plasma for Hepatitis B surface antigen and antibodies to HIV and Hepatitis C, considering these tests are done before the products are manufactured. 

Pooled blood plasma is a standardised product created by the combination of plasma collected from multiple donors, which is then processed, tested and used for therapeutic, diagnostic and research purposes. 

In a gazette notification amending the Drugs and Cosmetics Act, the Union Health Ministry said the requirement of final products to be tested for freedom from HIV I and HIV II antibodies, Hepatitis B surface antigen and Hepatitis C virus antibody shall be omitted. 

 

“The proposed amendment is a progressive step towards regulatory harmonisation, scientific rationalisation of testing requirements, and reduction of avoidable compliance burden while continuing to uphold the highest standards of patient safety,” the ministry said in a press note. 

It added that the first homogeneous pool of plasma is mandatorily tested for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA and antibodies to HIV, according to the harmonised standards of Indian, British, European and United States pharmacopoeias. 

“Pooled plasma must test negative for these viral markers before it is permitted for fractionation. Besides, only plasma pools that meet these safety requirements are used for manufacturing plasma-derived medicinal products,” the ministry stated. 

Despite this, experts said that under the current regulatory framework, the final products manufactured from already tested and qualified plasma pools are again tested. 

“This results in duplication of testing for the same viral markers at both the pooled plasma stage and the finished product stage, with such double testing not aligned with international regulatory practices,” an official in the know said. 

The Centre has invited objections and suggestions on the proposal from any person within 30 days. 

“Objections and suggestions which may be received from any person within the period specified above will be considered by the central government,” the gazette notification said